Smoking of tobacco products, such as cigarettes, cigars, and pipe tobacco, presents serious health risks to the tobacco user. Additionally, the use of smokeless tobacco products, such as chewing tobacco (both short and broad leaf tobacco) and snuff, can also result in serious health risks to the user.
While the serious health risks associated with the use of tobacco products are well documented and widely publicized, many habitual users are unable to quit using the tobacco products. The inability to quit using tobacco products can be primarily attributed to the fact that the user has developed a dependence on the nicotine that is present in the tobacco products. The dependence on nicotine manifests itself as nicotine cravings. Accordingly, a nicotine addicted tobacco user must continually use tobacco products to replenish the amount of nicotine in the blood, thereby satisfying the nicotine craving.
In order to successfully quit using tobacco products, the nicotine addicted tobacco user must overcome the nicotine cravings, thereby diminishing the desire to use tobacco products. Certain nicotine replacement therapies have been developed to assist the habitual tobacco user to quit using tobacco products. These nicotine replacement therapies attempt to temporarily replace some of the nicotine in the blood that is lost when a habitual user quits using tobacco products.
Nicotine replacement therapies have been developed and are provided in a variety of product forms. Such nicotine replacement products include, for example, nicotine containing gums, nicotine containing inhalers, nicotine containing transdermal patches, nicotine containing lozenges, and nicotine containing lollipops. Nicotine containing gums, lozenges and patches have enjoyed substantial commercial success.
One commercially available nicotine containing gum product is available under the trademark NICORETTE. The nicotine containing gums are generally supplied as individual pieces of chewable gum. The user removes an individual piece of the nicotine containing gum from the package and places it into the oral cavity. While the user is chewing the gum, nicotine is released from the gum and is absorbed by the oral mucosa. The nicotine containing gums, however, must be used at regular intervals in order to maintain steady levels of nicotine in the blood.
Nicotine containing gums may be used to relieve acute cravings experienced by a tobacco user that is attempting to quit smoking or smoke-less tobacco product use. For example, a single piece of gum may be self-administered by an individual in response to an acute nicotine craving. Such use of the nicotine gum typically results in an increase in blood nicotine levels to counteract the nicotine cravings. The tobacco user must repeatedly self-administer nicotine containing gums to maintain steady nicotine levels in the blood.
Commercially available nicotine containing transdermal patches include, for example, NICODERM, NICOTROL, and HABITROL. The nicotine transdermal patches are generally supplied as a patch having an adhesive backing covered by a release liner to protect the adhesive. The user of the patch removes the release liner from the patch to expose the adhesive backing. The adhesive backing is then applied to a suitable location on the dermis of the user, thereby adhering the patch to the user. Over time, nicotine is released from the patch and diffuses through the dermis and into the blood. The nicotine containing transdermal patches are useful for maintaining relatively steady blood level concentrations over time by providing the user with a substantially continuous infusion of nicotine while the patch is being worn.
Nicotine containing lozenges may be utilized in a similar manner as nicotine containing gums to provide relief from acute nicotine cravings. Commercially available nicotine containing lozenges include, for example, those lozenges sold under the trademarks COMMITS, STOPPERS, NIQUITIN, and NICOTINELLS. Similar to the nicotine containing gums, a tobacco user, instead of choosing to use a tobacco product, may self-administer a nicotine containing lozenge to alleviate a nicotine craving.
While commercially available nicotine replacement products provide some level of alleviation of both steady and acute tobacco cravings, there is still an ongoing need to provide more effective craving relief and to assist the tobacco user in quitting use of the tobacco products.
Films for delivering a pharmacologically or cosmetically active agent via the oral cavity have been developed. The films generally comprise water soluble films that disintegrate in the oral cavity and release the active agent that is incorporated the film. Nicotine has been incorporated into water soluble films, which upon disintegration of the film, releases nicotine into the oral cavity. The prior art has focused on water soluble thin films for achieving rapid disintegration or dissolution in the oral cavity, in order to alleviate acute nicotine cravings. For these rapidly disintegrating films, studies estimate that systemic absorption of the nicotine active is merely 25% of the total amount of the nicotine active initially present in the oral film dosage unit. This low level of absorption of the nicotine active through the oral mucosa can be directly attributed to the rapid disintegration of the oral film, which does not permit sufficient time for mucosal permeation. Thus, the vast majority of the nicotine active present in the oral film is simply swallowed.
The prior art nicotine containing oral films, however, do not address the difficulty associated with maximizing absorption of the nicotine active through the oral mucosa. Thus, there remains a need in the art for a slower disintegrating oral film that disintegrates at a rate that maximizes the absorption of the nicotine active through the oral mucosa, which thereby effectively delivers a dose of nicotine active to a user in a sufficient amount to reduce or eliminate nicotine cravings associated with the cessation of tobacco usage.